Kornimate/medical-research-clean huggingface dataset:
pain due to peripheral intravenous catheter insertion

Conditions: Pain

Summary: this study aimed to evaluate the effectiveness of rose oil aromatherapy and hand-holding in reducing pain associated with peripheral intravenous catheters (pivcs) insertion. study hypothesis: h0-1. the application of rose oil aromatherapy during the pivc insertion procedure does not reduce the pain associated with the procedure. h0-2. during the pivc insertion procedure, the patient's family holding the patient's hand does not reduce the pain associated with the procedure.


Eligibility criteria:
inclusion criteria: * patients voluntarily accepted to participate in the study, * aged between 18-65, * turkish literate, * pivc placement planned, * no hematoma, ecchymosis, scar and sensory change in the antecubital region, * suitable for pivc insertion with a 20 gauge (pink) catheter in the antecubital region, * who did not take analgesic drugs for 24 hours and were accompanied by a member of the patient's family (spouse or child). * patients with an enhanced adult diva (ea-diva) score below 8 for pivc placement in a single intervention, * the stai score below 40 exclusion criteria: * sensitive to smell and had problems in smelling, * patients with epilepsy, asthma diagnosis, * patients with a history of allergy
the effects of bifidobacterium breve bif195 for small intestinal crohn's disease

Conditions: Crohn Disease

Summary: the purpose of this study is to investigate if the probiotic bifidobacterium breve bif195 (bif195) will result in improvement in clinical outcome in patients with small intestinal crohn's disease.

crohn's disease (cd) is a chronic inflammatory bowel disease (ibd) with an incidence rate at 11/100 000 per year in denmark. the disease can potentially affect the entire gastrointestinal tract, though the most common affected area is terminal ileum and the adjacent part of colon. cd is a result of both genetic and environmental factors together with the intestinal microbiota, however the precise etiology is unclear. a change of the intestinal microbiota with a reduced occurrence of e.g. bacteroides species, firmicutes and the anti-inflammatory bacteria faecalibacterium prausnitzii is found in cd patients compared to healthy controls. also a reduction of the mucosa-associated bifidobacteria has been associated with the risk of mucosal inflammation. the hypothesis that an imbalance between potentially beneficial and pathogenic bacteria contribute to the pathogenesis of ibd, including cd, has led to the suggestion that manipulation of the microbiota may be an attractive target for therapeutic interventions in ibd. a new probiotic bacterium, bifidobacterium breve bif195 (bif195) has been identified and has shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy volunteers given acetylsalicylic acid (13), and thereby bif195 has also shown a potential in reducing gut permeability defects. this bacterium has not yet been investigated in cd patients.

Eligibility criteria:
inclusion criteria: * diagnosed with small intestinal cd * fecal calprotectin ≥ 250 ug/g * ius evidence of small bowel inflammation with wall thickness ≥ 4 mm * at least 3 months af stable medical treatment * able to read and speak danish exclusion criteria: * positive rectal swab for pathogenic microorganisms * use of antibiotics, probiotics and systemic glucocorticosteroids within 4 weeks prior to inclusion * participation in other clinical trials within 30 days prior to inclusion * pregnancy, planned pregnancy or breast feeding * psychiatric disease * abuse of alcohol or drugs

Keywords: probiotics
lindera obtusiloba for non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this randomized, open labelled, non-treatment-controlled study evaluates the safety and efficacy of lindera obtusiloba, a dietary food, on quality of life of non-small cell lung cancer patients who are receiving pd-1 or pd-l1 inhibitors.


Eligibility criteria:
inclusion criteria: * adults aged ≥ 20 years * patients who have understood and signed the informed consent. * subjects who have been confirmed histologically and radiologically for non small cell lung cancer and are scheduled to receive treatment with immune checkpoint inhibitors * subjects whose urine hcg are negative and who have agreed with the appropriate method of contraception in case of women of childbearing potential * subjects who can fully communicate with their medical doctor about their symptoms or quality of life and who can fill out questionnaires * subjects who can follow up during the clinical trial * eastern cooperative oncology group (ecog) performance status score ≤ 2 * hemoglobin ≥ 9g/dl exclusion criteria: * subjects who are pregnant, breastfeeding, planning to become pregnant or women of childbearing potential who do not agree with the appropriate method of contraception * subjects who have symptomatic and uncontrolled brain or central nervous system metastasis * subjects who complain of uncontrolled pain despite using analgesics * diastolic blood pressure\>100mmhg or systolic blood pressure\>160mmhg * alanine aminotransferase (alt) and aspartate aminotransferase (ast) levels higher than 2.5 times the upper limit for normal * creatinine level higher than 1.5 times the upper limit for normal * subjects who have participated in other clinical trials within 1 months * subjects with a history of serious drug allergies or who have hypersensitivity to the investigational product (the main ingredient and its components) * subjects with autoimmune diseases * subjects who have alcoholism or drug dependence * subjects who have cognitive impairment or psychiatric problems * subjects who have undergone surgery within 2 weeks * subjects who took other herbal medicine or other medicines within 4 weeks * subjects who have a medical condition that is likely to affect results or who are determined to be inappropriate to participate in this clinical trial at the investigator
the impact of different exercise modes on bile acid levels and liver function in patients with non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease NAFLD

Summary: the purpose of this clinical trial is to investigate which exercise regimen is more effective in improving non-alcoholic fatty liver disease (nafld) in a young population. the primary questions it aims to answer are: does aerobic training, resistance training, or a combination of both help improve liver function and glycemic and lipid parameters in nafld patients? which of these three exercise regimens is more effective in improving the aforementioned parameters? is the improvement in liver function related to bile acid metabolism? participants will: engage in physical exercise 4-5 times per week for two consecutive months, following a predefined exercise regimen. have blood samples collected to test for glucose, lipids, liver function, and other parameters before starting the exercise program and after two months of completing the regimen.


Eligibility criteria:
inclusion criteria: * body fat percentage \>20% or bmi \>24 * the diagnostic result of abdominal ultrasonography is fatty liver * no regular exercise under guidance in the past 3 months * no medication taken in the last month * no binge eating or heavy drinking in the past two weeks exclusion criteria: * long history of alcohol consumption, equivalent to more than 30g/day of ethanol * viral hepatitis * history of autoimmune or genetic diseases * history of drug-induced liver disease * history of total parenteral nutrition * history of cardiovascular, respiratory, or other diseases that necessitate avoidance of intense physical activity.

Keywords: non-alcoholic fatty liver disease aerobic exercise resistance exercise bile acids liver function
the effect of parathyroidectomy on renal function, endothelial function, and blood pressure

Conditions: Hyperparathyroidism; Hypertension

Summary: secondary hyperparathyroidism (hpt) is a known complication of chronic renal failure. elevated concentrations of parathyroid hormone (pth) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance, and hypertension. hpt is also known to play an important role in the development of structural abnormalities of both large arteries and the heart (left ventricular hypertrophy, interstitial fibrosis). in the last couple of years there has been increasing evidence from animal studies that the endothelium is a target organ of pth. hypothesis: pth has clinically relevant effects on renal hemodynamics, renal function and endothelial function. aims: 1. to evaluate the effect of parathyroidectomy (ptx) on renal hemodynamics in stable renal transplant recipients 2. to evaluate the effect of ptx on endothelial function in stable renal transplant recipients/chronic kidney disease (ckd) stage 5 patients 3. to evaluate the effect of ptx on blood pressure in stable renal transplant recipients/ckd stage 5 patients


Eligibility criteria:
inclusion criteria: 1. stable renal transplant recipients/ckd stage 5d patients. 2. age between 18 years and 85 years. 3. signed informed consent. 4. ptx scheduled because of severe hyperparathyroidism (day 0)

Keywords: parathyroidectomy arterial stiffness renal function
biological effects of citrate-buffered solutions on dialysis efficiency and systemic inflammation

Conditions: Renal Insufficiency, Chronic; Inflammation

Summary: in this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. the patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. the aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.


Eligibility criteria:
inclusion criteria: * age \>18 years * creatinine clearance \<5ml/min * treatment with bicarbonate hd (bic-hd) or on-line hemodiafiltration (ol-hdf) 3 times per week for at least 6 months prior to study start * treated at dialysis unit of: città della salute e della scienza university hospital, torino, italy exclusion criteria: * known neoplastic disease * active chronic inflammatory disease * active acute inflammatory disease
bridge device for post-operative pain control

Conditions: Liver Failure; Liver Diseases, Alcoholic; Liver Diseases; Pain, Postoperative; Transplant; Failure, Liver; Liver Cirrhosis, Biliary

Summary: auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. the investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. the investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.

this is a prospective, randomized study to determine the efficacy of the bridge device in reducing pain and opioid use in patients following liver transplantation. subjects will be randomized in a 1:1 ration to one of the below groups: group 1: bridge device will be placed prior to start of the surgery with standard of care pain control analgesia group 2: subjects will receive the standard of care pain control analgesia

Eligibility criteria:
inclusion criteria: * inclusion criteria: * ≥18 years of age but \<70 years of age * actively listed for isolated liver transplantation * subject or legally authorized representative able to sign informed consent * not currently treated with opioids or any medications that may interact with opioids * english speaking * willing and able to participate and consent to this study exclusion criteria: * diagnosis of acute liver failure or primary sclerosing cholangitis (psc) * anticipated that the subject will require a new roux-en-y hepaticojejunostomy * current use of opioid use or other substance abuse. * chronic pain disorders * need for regional anesthesia (regional nerve blocks or epidurals) * adhesive allergy/sensitivity * subject admitted to the icu at the time of transplant
effects of age and obesity on brain insulin sensitivity

Conditions: Insulin Resistance; Obesity

Summary: obesity and especially type 2 diabetes (t2d) increases the risk of neurocognitive dysfunctions including adverse effects on brain structure and function. recent evidence from clinical studies have shown that t2d almost doubles the risk for dementia. as the population gets older, age-related chronic diseases, as t2d, become more prevalent. scientific evidence is emerging that there are several links between metabolic and neurocognitive functions. impaired insulin action (i.e. insulin resistance), the main hallmark of t2d, has been suggested as a likely shared common pathophysiological mechanism. however, the neural processes that determine how insulin resistance is are connected to the onset and progression of t2d and dementia remain unclear. in this context, the overall aim is to study brain insulin resistance to disentangle age-related and obesity related brain insulin resistance in healthy normal and overweight/obese persons at the age of 20 to 70 years . to this end, the investigators will assess brain insulin action using intranasal insulin/placebo during functional magnetic resonance imaging (fmri). additionally, structural changes and cognitive processes will be assessed as secondary variables.


Eligibility criteria:
inclusion criteria: * body-mass index (bmi) between 19-35 kg/m2 * hba1c ≤6.0% * normal glucose tolerance during 75g oral glucose tolerance test (ogtt) exclusion criteria: * not removable metal parts in or on the body * manifest cardiovascular disease * claustrophobia * recent surgery (less than 3 months) * simultaneous participation in other studies * acute disease or infection within the last 4 weeks * neurological and psychiatric disorders * treatment with centrally acting drugs * hemoglobin hb \<13g / dl * hypersensitivity to any of the substances used
development of new methodologies and innovative tools for the diagnosi and therapeutic treatment of umani epithelial tumors

Conditions: Cancer Risk; Breast Cancer Risk; Lung Cancer (NSCLC)

Summary: the main objective of the sistema project is to develop non-invasive diagnostic tests for the detection and quantification in blood of markers of mesenchymal epithelial transition, a mechanism that characterises certain types of cancer such as breast and lung cancer. cancer is still one of the leading causes of death in western countries. in 2014, there were an estimated 1,665,540 new cancer cases and 585,720 deaths in the united states alone. the world health organisation (who) and eurostat predict 1,323,600 deaths in europe, a figure slightly down on previous statistics but still underlining the existence and seriousness of the problem. it is no coincidence that cancer is one of the main areas of investment in the european horizon 2020 programme. in recent years, the hypothesis that the process of carcinogenesis is driven by the activation of a particular panel of genes/proteins that enable cancer cells to acquire malignant characteristics has become increasingly popular. this process goes by the name epithelial mesenchymal transition (emt) and characterises all human epithelial tumours. this process allows epithelial tumour cells to acquire mesenchymal characteristics giving them stem, invasive, and chemoresistant properties.


Eligibility criteria:
inclusion criteria: * male and female subjects over the age of 18 years with an established clinical picture of breast or lung cancer (including mesothelioma) who have not yet started chemotherapy or biological therapies for the treatment of the neoplastic disease and who have read, understood and signed the study information sheet with attached informed consent to participation, signing the attached consent. exclusion criteria: * pregnant female patients of either sex under the age of 18 years, undergoing previous drug therapy with corticosteroids, chemotherapies, immunosuppressants and anticancer drugs, as well as patients with a previous history of other malignancies or in a terminal state (life expectancy less than 4 weeks). furthermore, lung cancer patients with conditions that could potentially interfere metabolically with the l-fucose biomarker tested in the specific project arm will be excluded, i.e. lung cancer patients simultaneously suffering from: cirrhosis of the liver, gastric ulcer, diabetes mellitus, periodontitis, as well as subjects under stressful conditions (in which false positivity to the marker due to adrenalin release could occur).
the effects of seasonal changes in osteoporosis treatment

Conditions: Selective Estrogen Receptor Modulator (SERM)

Summary: there are few reports concerning to the seasonal variation of osteoporosis treatment. in this study, we plan to compare clinical efficacy and safety by seasons.

vitamin d insufficiency is common in many countries. vitamin d insufficiency is associated with osteoporosis and the responses to osteoporosis treatment. 25-hydroxyvitamin d (25ohd) is considered to be the best estimate of body stores of vitamin d and the seasonal variation of 25ohd is well known. but there are few reports concerning to the seasonal variation of osteoporosis treatment. in this study, we plan to compare clinical efficacy and safety by seasons in patients treated by raloxifene.

Eligibility criteria:
inclusion criteria: * postmenopausal women exclusion criteria: * patients who could not use serm

Keywords: serm season variation vitamin d
arthroscopic superior capsular reconstruction - study of different types of grafts

Conditions: Rotator Cuff Tear; Graft Complication

Summary: multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ascr) when a different type of graft is used.

patients with irreparable rotator cuff tears who meet the eligibility criteria will be enrolled in the study and undergo arthroscopic superior capsular reconstruction using one of the following types of graft: fascia lata autograft, fascia lata allograft, achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft. all patients will be assessed clinically, radiologically and with an mri preoperatively and at the 6-months and at the 2-years postoperative evaluations. the range of motion (rom), shoulder abduction strength, constant (cs), simple shoulder test (sst) and subjective shoulder value (ssv) scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 2 years postoperative (paired-samples t-test, two-tailed) in each group (allotment to groups is performed according to the type of graft used: fascia lata autograft, fascia lata allograft, achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft). the differences in rom, shoulder abduction strength, cs, sst and ssv scores from preoperative to 6 months postoperative and from 6 months postoperative to 2 years postoperative will be compared between groups. all continuous variables will be compared between the group of patients with graft tears and the group without graft tears (mann-whitney u test). all categorical variables and outcome results will be compared between groups (fisher's exact test). a significant difference will be defined as p\<0.05.

Eligibility criteria:
inclusion criteria: * rotator cuff tear arthropathy, hamada stage 1 or 2 * complete rotator cuff tendon tear involving one or more tendons, with a patte stage 3 tendon retraction on the preoperative magnetic resonance imaging exclusion criteria: * rotator cuff tear arthropathy, hamada stage 3 or 4 * complete rotator cuff tendon tear involving one or more tendons, with patte stage 1 or 2 tendon retraction on the preoperative magnetic resonance imaging * proximal humerus fracture * acute shoulder dislocation (in the previous 8 weeks)

Keywords: arthroscopic superior capsular reconstruction irreparable rotator cuff tear allograft autograft xenograft
analysis of novel positioning sensor-assisted postoperative position correction and effective prone time recorded in patients with different prone times after macular hole surgery

Conditions: Idiopathic Macular Hole; Effective Prone Time

Summary: idiopathic macular hole (imh) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. it is often associated with loss of central vision, visual distortion, and other ocular manifestations. it is currently treated by vitrectomy combined with internal limiting membranes (ilm) peeling followed by gas filling. a strict prone position for a certain period of time after surgery has a positive effect on the healing of the macular fissure. the need for a strict prone position after imh has been demonstrated in previous studies (especially when the imh diameter is \>400 μm). however, due to the anti-human mechanics of the face-down position, patient comfort, sleep quality and quality of life are greatly compromised. therefore, this study designed a smart head position monitoring device to assist patients in maintaining the correct position and recording the effective position time. the study was conducted to determine the shortest prone position time based on macular fissure closure, to minimize the adverse effects of postoperative position, and to obtain the maximum recovery of visual acuity and visual field.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older； * patients diagnosed with imh; * patients requiring face-down position after vitrectomy combined with ilm peeling and c3f8(14%) gas filling; tolerated face-down position after surgery; * agreed to the study protocol. exclusion criteria: * myopia greater than or equal to -6.0 d; eye axis length (al) greater than 26.0mm; * trauma, macular edema, macular degeneration, and other secondary mh with clear etiology; * previous history of internal eye surgery in the operated eye; * patients with local or systemic other diseases significantly affecting visual function; * those who cannot maintain face-down position after surgery due to systemic factors, etc.